Almac Group Launches TempEZ™ Site Storage Temperature Compliance Module
April 25, 2019
A truly end-to-end regulatory compliant clinical supply chain solution
Durham, N.C., 25 Apr 2019 – Almac Clinical Services, part of the Almac Group, the global contract pharmaceutical development and manufacturing organization, has today announced the launch of the Site Storage Temperature Compliance module to its TempEZ™ platform. This additional component provides customers with a solution to digitize, visualize and manage temperature data held by the clinical sites.
TempEZ is Almac’s market leading web-based, temperature data management software. It provides sponsors with a single, secure database to collect the temperature data, required by GDP regulations, to prove their products have been stored within the label claim throughout the supply chain. TempEZ gives clients data visibility from manufacture to patient administration, flexibility to utilize any monitor brand, automates excursion management and moves data from paper to computerized records.
TempEZ’s Site Storage Temperature Compliance module, developed by Almac’s global in-house experts, is a welcome addition to Almac’s already established temperature management portfolio. The bespoke solution was developed to reduce the data collection burden at clinical sites and to improve the visibility of temperature data held by the clinical sites for both clients and CROs. The solution essentially closes the data gap which currently exists at clinical sites making temperature data visible and readily available.
“Almac’s TempEZ is the only software platform that offers sponsors a complete, end-to-end temperature history of their drug product,” explains Donna Christopher, Global Vice President Operations, Almac Clinical Services. “The focus for temperature data collection has typically been on transit data. However, drug products spend more time at the clinical site than in transit, resulting in the majority of temperature excursions occurring at the site. We need to focus our data collection efforts at this point to enable these excursions to be identified and adjudicated quickly, thus safeguarding the patient. In the current climate, sponsors have difficulty accessing temperature data held at the clinical sites. This release of TempEZ digitizes any form of temperature data and makes it visible and readily available to sponsors and CROs. In addition, CRAs can remotely query the data directly from TempEZ. I am delighted to announce the launch of our new functionality.”
Find out more about Almac’s TempEZ solution here.
Join Almac’s Supply Chain Solution Managers, Heather Bogle and Sarah Smyth at the upcoming, Global Clinical Supplies Group (GCSG) conference in San Antonio, US from 28th April – 1st May as they present ‘Temperature Data at the clinical site; the missing piece of the puzzle’.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.
Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).